New drug combo shows promise for Hard-to-Treat cancers
NCT ID NCT07169994
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a new drug called YL202 combined with other anti-cancer medicines (toripalimab or furmonertinib) in people with advanced solid tumors, including breast and lung cancer. The goal is to find safe doses and see if the combination shrinks tumors. About 414 adults aged 18-75 who have tried standard treatments are being recruited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- YL202 (a drug) combined with toripalimab or furmonertinib mesilate
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial (phase Ib/II) with a small number of participants, so the safety and effectiveness are not yet proven. There is a risk of side effects, and the combination may not work for all tumor types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 414 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF) 2. Able and willing to comply with protocol visits and procedures 3. Aged between 18 to 75 years 4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 5. Previously treated by standard treatment or have not been treated for metastatic setting; 6. Adequate organ and bone marrow function. 7. Have at least 1 extracranial measurable tumor lesion. 8. Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy. Exclusion Criteria: 1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \[ADCs\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs). 2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors. 3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study. 4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product. 5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study. 6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation. 7. Prior treatment with systemic steroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product. 8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period. 9. With meningeal metastasis or cancerous meningitis. 10. With brain metastasis or spinal cord compression. 11. Patients with uncontrolled or clinically significant cardiovascular diseases. 12. Clinically significant complicated pulmonary disorders. 13. Patients diagnosed with Gilbert syndrome. 14. Those with uncontrolled effusion in the third space requiring repeated drainage. 15. With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator. 16. With serious infection before the first dose. 17. With known human immunodeficiency virus (HIV) infection. 18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product. 20. Unrelieved toxicity of previous anti-tumor therapy. 21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies. 22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose. 23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
20 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Affiliated Hospital Of Hebei University
NOT_YET_RECRUITINGBaoding, Hebei, 71051, China
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Affiliated Zhongshan Hospital Dalian University
NOT_YET_RECRUITINGDalian, Liaoning, 116001, China
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Affiliated Zhongshan Hospital Dalian University
NOT_YET_RECRUITINGJinan, Shandong, 250117, China
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Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)
NOT_YET_RECRUITINGHefei, Anhui, 230001, China
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Anyang Cancer Hospital
NOT_YET_RECRUITINGAnyang, Henan, 455100, China
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 201321, China
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Fujian Cancer Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, 350014, China
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Ghang xi Medical University Cancer Hospital
NOT_YET_RECRUITINGNanning, Guangxi, 530028, China
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Harbin Medical University Cancer Hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150081, China
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Jiangsu Province Hospital（The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital)
NOT_YET_RECRUITINGNanjing, Jiangsu, 210029, China
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Jiangxi Cancer Hospital
NOT_YET_RECRUITINGNanchang, Jiangxi, China
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Liaoning cancer hospital &institute
NOT_YET_RECRUITINGShenyang, Liaoning, 110042, China
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Meizhou People's Hospital（Huangtang Hospital）Meizhou Academy of Medical Sciences
NOT_YET_RECRUITINGMeizhou, Guangdong, 514031, China
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Shanxi Cancer Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, 30013, China
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Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital
NOT_YET_RECRUITINGSichuan, Sichuan, 610072, China
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Sun Yat-sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510555, China
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The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITINGLuoyang, Henan, 471023, China
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The First People's Hospital of Changde City
NOT_YET_RECRUITINGChangde, Hunan, 415000, China
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Tianjin Cancer Hospital Airport Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300300, China
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Xiangyang Central Hospital
NOT_YET_RECRUITINGXiangyang, Hubei, 441138, China
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